Spectre guidewire
FDA 510(k) K163444 · Vascular Solutions, Inc.
510(k) numberK163444
Submission
- Device name
- Spectre guidewire
- Applicant
- Vascular Solutions, Inc.
Minneapolis, MN, US - Received
- December 8, 2016
- Decision date
- January 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
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More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon…LOX · Traditional | 05/31/2024SE |
| K230637 | Wattson temporary pacing guidewire (2250)DQX · Traditional | 05/05/2023SE |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…DQY · Special | 08/18/2022SE |
| K221470 | Langston dual lumen catheterDQO · Special | 06/17/2022SE |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…DQY · Traditional | 02/09/2022SE |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireDQX · Traditional | 02/09/2022SE |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterDQY · Traditional | 04/30/2021SE |
| K193119 | Twin-Pass Dual Access CatheterDQY · Traditional | 06/29/2020SE |
| K200720 | D-Stat Radial Topical HemostatQSX · Special | 06/26/2020SE |
| K192454 | Wattson Temporary Pacing GuidewireDQX · Traditional | 01/15/2020SE |
Questions and answers
When was Spectre guidewire cleared by the FDA?
Spectre guidewire (K163444) received a 510(k) decision of Substantially Equivalent on January 6, 2017, 29 days after the submission was received.
What is the product code of K163444?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.